RheOx Registry Study in Europe

Gala Therapeutics

Status: Enrolling

Conditions: Chronic Bronchitis; COPD

Treatments: Device: RheOx

Study type: Interventional

Funder types: Industry

Identifiers

NCT04182841

CS005

Details and patient eligibility

About

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

Full description

RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.

Subjects will be required to submit to several tests and questionnaires during the study including respiratory function tests.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has moderate to severe Chronic Bronchitis

Exclusion criteria

• Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device.
• Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block.
• Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

RheOx Treatment

Other group

Description:

RheOx is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Treatment:

Device: RheOx